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By The Thesis Committee, Examination Department, Business School, The University of Lahore
Guidelines
For Bachelors And Masters Thesis.
Business School The University of Lahore
December 2010 Contents:
1. Introduction 2. Thesis Process Summary 3. Thesis Guidelines 4. Thesis Proposal Format 5. List of Topics
Sample A: Title Page Sample B: Signature Page Sample C: Table of Contents Sample D: References Sample E: Thesis text format
By The Thesis Committee, Examination Department, Business School, The University of Lahore
1 Introduction The thesis is a very important and integral part of your academic studies, therefore you should be prepared to put in a lot of hardwork and effort. This work should be done in the right direction and for this we have prepared this information pack to guide you through the process. The thesis is an opportunity for you to apply some of your learning from your academic studies. You may have to develop this learning in more depth to prepare a high quality thesis and this will enhance your knowledge and skills in accounting and finance. The purpose of the thesis is to give you an opportunity to demonstrate a range of Technical and Professional Skills in:
Understanding of accountancy / business models Application of accountancy / business models Evaluation of information, analysis and conclusions Presentation of project findings
and high level skills in:
Communication Information gathering and referencing Information technology
By The Thesis Committee, Examination Department, Business School, The University of Lahore
3 Thesis Proposal Format A proposal is a statement of intent. It is a difficult document, because it has to be written before you have done the research. It should consist of 750 words (+/-10%) and must quickly and simply communicate your research project to any reader. The proposal will likely require a number of drafts before you get it right, but each will bring greater clarity to your project. A proposal should be written in an active voice, and make statements like, this research will, do so-and-so. You can break the text up with sub-headings, suggestions for which are included in the numbered sections below. But any reader will want to know what you will work on, why its important and how you will do it. One way to convey this is to make clear what your main research questions are, why these are important questions to research and how you are going to do the research to answer the question. The reader will also require a quick picture of the overall structure of the thesis, and section 5 below will help to deliver this. 1. Introduction: Following the title, open your proposal with a simple and strong statement describing your research topic. Use only a couple of sentences for this, and quickly show the reader what issue you intend to tackle. This needs to be more focused than merely to name a field of study. Remember also that you can give additional detail later in the document. To construct these introductory sentences, ask yourself: What is the central problem I am interested in? What specific question(s) will I investigate? What hypothesis does my research seek to test? What is my research about? What is its primary aim? What will it do? 2. Background to the Project: Try to state, in a second paragraph, why it is that your chosen problem is important. Here, you begin to give background to the research project, and to outline the way in which your question relates to current debates in your area of study. It concludes with the reason your chosen topic is important. How do you justify your project? What is the point of doing it? What other research is going on around this topic? What is original about your project? What do you have to say thats different? 3. Project Outline: Here, you can give more detail on what you will actually do. Having established why your project is important and new, and how it relates to existing research,
By The Thesis Committee, Examination Department, Business School, The University of Lahore
you now have an opportunity to give more detail on precisely what your project will entail. What additional detail on the nature of the project does the reader require? Is there a particular secondary question you intend to address? What will your research achieve or produce? 4 Research Methods: Try to describe how you intend to go about researching your chosen problem. It is here that you show the research method(s) (sometimes referred to as methodology) you will use to collect data, and the areas of knowledge you will need to cover in order to deliver on your aims. What literature, data, bodies of knowledge, must be covered in order to deliver this thesis? What research methods will you use to collect data? (Quantitative / Qualitative). Is the research primarily empirical or theoretical? If both, how will they be weighted and how will they relate? Is there a comparative component to your research, and if so, how will this work? Do you need special research or language skills to collect your data? If so, do you have them? If not, how do you plan to get them? What problems must you allow for in using these research methods? Are there any ethical or confidentiality issues arising? 5. Provisional Chapterisation: To give a sketch of how the thesis will be structured, list around six chapter headings with clear and communicative titles. Put a couple of sentences under each to show what will be in them. Indicate some of the literature to be covered in each chapter by including names in brackets. 6. Bibliography: Up to ten key sources for your data. Submission: Submit the Project proposal in a Plastic file to your project mentor with your contact details written in the back inside cover. You may only start work on project after approval of your proposal by your mentor. This approved proposal must be attached along with your thesis when upon submission.
By The Thesis Committee, Examination Department, Business School, The University of Lahore
4 Thesis Guidelines Thesis: Format and presentation _____________________________________________________________________ It is essential that the Thesis follows the presentation and formatting requirements strictly as per the following guidelines and Sample Formatting Annexures. Failure to do so will result in project rejection / marks penalization. LENGTH: The total length should be as follows: Degree Program Min Max BS (Hons) 12,000 15,000 MS (Hons) 15,000 18,000 MPhil 18,000 24,000 The University of Lahore reserves the right to penalize / reject thesis which do not meet the word count limit & guidelines. Footnotes, references and text within tables are to be counted within the word-limit, but captions, appendices and bibliographies are excluded. The breakup of the word count should be as detailed in section named Structure of Part 1, 2 & 3 below. You are required to attach a word count to your thesis. To do so, print out the word count on an otherwise blank piece of paper and include it as the last page in your thesis. Theses will not be accepted/marked without a total word count, and word-count for each chapter of the thesis. WORD-PROCESSING. Should be on one side of the sheet only and should be single spaced. Pages should be numbered. PAGE NUMBERING: Beginning with the first page of the Acknowledgements or Preface, if used, all preliminary pages preceding the actual text must be numbered in lowercase Roman numerals; e.g., iii, iv, v, etc. These numerals must be centered under the text with at least one inch of space between the number and the bottom of the page. If no optional pages are used, the page numbers must begin on the Abstract. Do not number the copyright page, title page,
By The Thesis Committee, Examination Department, Business School, The University of Lahore
signature page, or dedication, but do include each of them in the pretext page count. Do not count the fly page. The first page of the text begins at Arabic numeral 1. All pages within the text must contain an Arabic page number, bottom-centered, at least one inch from the bottom edge of the page. The first page of every major section (chapters, appendices, bibliography, Vita, etc.) must begin on a new page. FINANCIAL DATA: Wherever financial data is involved excel sheet will be used by integration in MS Word. FONT: Size 12, Times New Roman or Arial Font ONLY to be used for the thesis. Size 10 to be used for footnotes. Single spacing should be used throughout the thesis. MARGINS: Should be eight spaces (one inch) at the top and bottom of each page, with two inches at the left edge and one inch at the right. FOOTNOTES: Follow the foot- or end-noting conventions of the discipline with which the essay is most closely associated. If notes are given at the bottom of the page, a continuous line should be drawn from margin to margin between the text and the footnotes (or as long a line as possible). TABLE OF CONTENTS: The table of contents should be structured in a way as illustrated in the sample attached. BINDING: The thesis should be bound in a black hard leather binding. The title page imprinted on the front cover of the thesis should follow the Standard Formatting as attached in these guidelines. SUBMISSION: Two copies of the Hard Bound Thesis along with 2 soft Copies in Rewritable-DVD should be submitted to the Examinations Department, along with your contact details and number written at the front cover of the thesis. Failure to do so will result in delays. In addition you must email the softcopy in MS Word format & PFD format to [email protected] with your name and project name in the subject line. All excel workings should also be included in the DVD-RW and
By The Thesis Committee, Examination Department, Business School, The University of Lahore
also emailed as a separate file. After submission the Thesis all submissions will be the property of UoL. LAST DATE FOR SUBMISSION: This will be displayed on the notice board at the beginning of the semester. Failure to do so will result in you being considered as having failed in the thesis and you will enroll for the thesis again in the next semester after payment of prescribed repeat fee. Note on Plagiarism / Copying: Plagiarism Policy of UoL Plagiarism is a serious academic offense and students are responsible for educating themselves about it. Plagiarism is a form of dishonesty that occurs when a person passes off someone else's work as his or her own. This can range from failing to cite an author for ideas incorporated into a student's paper to cutting and pasting paragraphs from different websites to handing in a paper downloaded from the internet. All are plagiarism. There are three central things all UoL students should know about the consequences of plagiarism: 1) Plagiarism is a university offense. Professors are expected to report all instances of plagiarism to their respective department, which then initiates a review of its own. In other words, in addition to dealing with the course instructor, students who plagiarize must also deal with the University. Students found guilty of plagiarism will have this entered into their record and may be expelled from the university. 2) Plagiarism in most instances is easy to identify and expose. The very force that makes plagiarism easy and tempting to some students--the internet--makes its detection easy. Most professors can locate the source of suspected plagiarism within a few minutes of searching the web. In this context, plagiarism is as much stupidity as it is dishonesty. 3) All parties to plagiarism are considered equally guilty. If you share your work with another student and he or she plagiarizes it, you are considered as guilty as the one who has plagiarized your work, since you enabled the plagiarism to take place. Under no circumstances should a student make his or her coursework available to another student unless the instructor gives explicit permission for this to happen.
By The Thesis Committee, Examination Department, Business School, The University of Lahore
In other words, students who plagiarize are likely to be caught, and the consequences will be severe and will include anyone who enabled the plagiarism to take place. University policy will kick in, regardless of the feelings of either the students or the instructor. Avoid plagiarism at all costs! Note on Referencing Referencing is a standardised method of acknowledging sources of information and ideas that you have used in your assignment in a way that uniquely identifies their source. Direct quotations, facts and figures, as well as ideas and theories, from both published and unpublished works must be referenced. There are many acceptable forms of referencing. The official referencing style adopted by the Business School, UoL is the Harvard referencing style. Within the text of the assignment the authors name is given first, followed by the publication date. A reference list at the end of the assignment contains the full details of all the in-text citations. Referencing is necessary to avoid plagiarism, to verify quotations, and to enable readers to follow-up and read more fully the cited authors arguments. For details of how to reference according to the Harvard Style please consult the following website: http://libweb.anglia.ac.uk/referencing/harvard.htm Copying from other books, websites, documents, etc In all of the thesis a maximum of only Quarter of a page data can be copied in totality from any one book, website or any one source; and this too is subject to you giving its reference. If more than Quarter of a page is copied your thesis will be rejected. Students are advised to check their work for plagiarism using atleast 5 different internet based/program based plagiarism software. The work of all students is subject to a international plagiarism check, for which a fee of Rs 750 will charged.
By The Thesis Committee, Examination Department, Business School, The University of Lahore
Arrangement of Thesis
1. Title page: (Sample A) 2. Signature Page: (Sample B) 3. Original Project Assignment Form 4. Acknowledgements page (optional) 5. Abstract (i.e. Executive Summary) page. 6. Table of Contents page (Sample C) 7. List of Tables / Figures (Optional) 8. Part 1- project objectives and overall research approach 9. Part 2- information gathering and accounting / business techniques 10. Part 3- results, analysis, conclusions and recommendations 11. References used (Sample D) 12. Appendices
By The Thesis Committee, Examination Department, Business School, The University of Lahore
Structure of Part 1, 2 & 3 of Thesis PART 1 - Project objectives and overall research approach 15% of your word count The first part of your thesis 'sets the scene' It should include the following: The reasons for choosing your project topic area and choosing the particular organization that was the focus of your research work What you wanted to find out in your research work. i.e. your project objectives and research questions An explanation of your overall research approach. This should provide the reader with an understanding of the overall framework that you developed to meet your project objectives and answer your research questions. PART 2 - Information gathering and accounting / business techniques 25% of your word limit. The second part of your Research Report should provide more detail about:
(i) the information that you have gathered and (ii) the accounting and business techniques you have chosen to apply to
this information. It should include the following:
The sources of information from which you have obtained relevant data
A description of the methods used to collect information, including online access
A discussion of the limitations of your information gathering Identification of any ethical issues that arose during your
information gathering and how they were resolved An explanation of the accounting and / or business techniques you
have used, including a discussion of their limitations.
By The Thesis Committee, Examination Department, Business School, The University of Lahore
PART 3 - Results, analysis, conclusions and recommendations 60% of your word limit. The third part of your thesis should provide a detailed account of what you have found from the application of your chosen accounting and business techniques to the information that you have gathered. It should include:
A description of the results you have obtained and any limitations Presentation of your results in an appropriate form e.g. tables, graphs, pie
charts A critical analysis / evaluation of your results which includes an
explanation of your significant findings Your conclusions about your research findings and how well you have
met your project objectives and research questions If appropriate, recommendations on specific courses of action to identified
individuals within your chosen organisation.
By The Thesis Committee, Examination Department, Business School, The University of Lahore
5 Thesis Topic Areas You are advised to select a topic area from the topics provided to you seperately. Your research proposal should clearly describe the specific research you are going to conduct in the area of your choice.
By The Thesis Committee, Examination Department, Business School, The University of Lahore
Sample A: Title page Here is an example of the text that should be appropriately centered and spaced on the title page:
(title of thesis)
A Thesis Presented
by
(first name, middle name, and last name of author)
(UoL Registration Number)
to
The Committee on Academic Degrees
in partial fulfillment of the requirements for a degree with honors
of BSc / MSc / MPhil (Hons)
( UoL logo here without Ayat.)
Business School, The University of Lahore
(month and year)
By The Thesis Committee, Examination Department, Business School, The University of Lahore
Sample B: Signature Page The Thesis committee for (Insert your full name) Certifies that this is the approved version of the following thesis:
Title of Thesis
APPROVED BY SUPERVISING COMMITTEE:
Supervisor: ________________________________________ (Name typed under line) __________________________________________ (Name typed under line)
iii
TABLE OF CONTENTS
Declaration .............................................................................................................. ii
Table of Contents......................................................................................................... iii
List of Figures and Tables..........................................................................................viii
List of Figures ....................................................................................................viii
List of Tables ........................................................................................................ x
Acknowledgements...................................................................................................... xi
Abstract ...........................................................................................................xiii
Chapter 1 Introduction ........................................................................................... 1
1.1 Thesis Motivation...................................................................................... 1
1.2 Research Aims and Questions.................................................................... 2
1.3 Significance and Innovation....................................................................... 3
1.4 Structure of This Thesis ............................................................................. 5
Chapter 2 Literature Review .................................................................................. 7
2.1 Introduction ............................................................................................... 7
2.2 The Australian Biotechnology Sector......................................................... 8
2.2.1 Evolution of a Sector........................................................................ 11
2.2.1.1 International Biotechnology ......................................................... 11
2.2.1.2 Australian Biotechnology............................................................. 13
i Victoria............................................................................................ 15
ii NSW................................................................................................ 16
iii Queensland ...................................................................................... 16
iv Western Australia ............................................................................ 17
v South Australia ................................................................................ 18
vi Australian Capital Territory ............................................................. 18
vii Tasmania...................................................................................... 18
2.2.2 Funding ........................................................................................... 19
2.2.3 Government Support ........................................................................ 23
2.2.4 Listed Companies ............................................................................ 24
2.2.5 Australia as a Global Competitor ..................................................... 26
2.3 IPOs ........................................................................................................ 27
WindTypewriterSample C: Table of Contents
iv
2.3.1 Information Asymmetry................................................................... 28
2.3.2 Uncertainty ...................................................................................... 28
2.3.3 Signalling Hypothesis ...................................................................... 30
2.3.4 Entrepreneurial Wealth .................................................................... 30
2.3.5 Sentiment......................................................................................... 31
2.3.6 Australian Observations ................................................................... 32
2.3.7 IPO Underpricing in the Biotechnology Context .............................. 34
2.4 Valuation................................................................................................. 36
2.4.1 Discounted Cash Flow ..................................................................... 37
2.4.1.1 Methodological Summary ............................................................ 38
2.4.1.2 Limitations................................................................................... 38
2.4.1.3 Discounted Cash Flow Methodological Extensions ...................... 39
i Non-constant discount rate............................................................... 40
ii Probability weighted decision tree.................................................... 40
iii Monte Carlo scenario testing............................................................ 41
2.4.2 Real Options Valuation .................................................................... 41
2.4.2.1 Methodological Summary ............................................................ 43
i Binomial Decision Tree ................................................................... 43
ii Binomial Lattice .............................................................................. 43
iii Black Scholes .................................................................................. 44
2.4.2.2 Limitations................................................................................... 44
2.5 Conclusion .............................................................................................. 45
Chapter 3 Methodology ....................................................................................... 47
3.1 Introduction ............................................................................................. 47
3.2 Research Aims and Questions.................................................................. 47
3.3 Research Design ...................................................................................... 48
3.3.1 Multi-Method Research ................................................................... 48
3.3.2 Research Structure ........................................................................... 50
3.4 Qualitative Sector Investigation ............................................................... 52
3.4.1 Interview schedule ........................................................................... 52
3.4.2 Ethical Considerations ..................................................................... 53
3.4.3 Invitation process & participant information .................................... 54
3.4.4 Data Analysis................................................................................... 55
3.5 Quantitative Review of Initial Public Offerings ....................................... 58
3.6 Quantitative Review of Valuation Methodologies .................................... 59
References
- 215 -
REFERENCES
Abrantes-Metz, RM, Adams, CP & Metz, AD 2005, 'Pharmaceutical Development Phases: A Duration Analysis', Journal of Pharmaceutical Finance, Economics & Policy, vol. 14, no. 4, pp. 19 - 41. Adams, CP & Brantner, VV 2006, 'Estimating The Cost Of New Drug Development: Is It Really $802 Million?' Health Affairs, vol. 25, no. 2, pp. 420-8. Aegis 2006a, August 2006 A Winter Chill Settles Over the Sector. ---- 2006b, August 2006 A Winter Chill Settles Over the Sector, viewed 05/10/06 2006, . Akerlof, GA 1970, 'The Market For 'Lemons': Quality Uncertainty and the Market Mechanism', Quarterly Journal of Economics, vol. 84, no. 3, pp. 488-500. Allen, F & Faulhaber, GR 1989, 'Signaling by Underpricing in the IPO Market', Journal of Financial Economics, vol. 23, no. 2, pp. 303-23. Allergan Drug Development Process, viewed 01/11/06 2006, . Amit, R & Livnat, J 1989, 'Efficient Corporate Diversification: Methods and Implications', Management Science, vol. 35, no. 7, pp. 879-97. Amram, M & Kulatilaka, N 1999, Real Options: Managing Strategic Investment in an Uncertain World, Harvard Business School Press, Boston. Anderegg, MH, Thayer, JM & Williams, KM 2006, Trendspotting: betting strong but playing safe, Nature, viewed 15/06/06 2006, . Arkebauer, JB & Schultz, R 1991, Cashing out: The entrepreneurs guide to going public, Harper Business, New York. Australian Bureau of Statistics 2005, 5678.0 Venture Capital, viewed 07/11/06 2006, . ---- 2006a, 6401.0 March Quarter 2006, viewed 28/05/06 2006, .
References
- 216 -
---- 2006b, 1301.0 Year Book Australia, viewed 28/05/06 2006, . Australian Government 2000, Australian Biotechnology: A National Strategy, Commonwealth of Australia, viewed 10/06/06 2006, . ---- 2003, Summary of the Outcomes from the 2003 Evaluation of the National Biotechnology Strategy and Biotechnology Australia, viewed 25/10/06 2006, . ---- 2004, Sustaining the Virtuous Cycle For a Healthy, Competitive Australia, Commonwealth of Australia. ---- 2006, Snapshot of biotechnology in Australia, viewed 02/11/06 2006, . Banz, RW 1981, 'The Relationship Between Return and Market Value of Common Stocks', Journal of Financial Economics, vol. 9, no. 1, pp. 3-18. Barnes, K 2006, Overcoming drug development challenges, viewed 30/05/06 2006, . Barron, OE, Byard, D, Kile, C & Riedl, EJ 2002, 'High-technology intangibles and analysts' forecasts', Journal of Accounting Research, vol. 40, no. 2, pp. 289-312. Beatty, RP & Ritter, JR 1986, 'Investment banking, reputation, and the underpricing of initial public offerings', Journal of Financial Economics, vol. 15, no. 1-2, pp. 213-32. Belsey, MJ & Pavlou, AK 2005, 'Trends underlying early-stage drug discovery and development collaborations from October 2002 to September 2004', Journal of Commercial Biotechnology, vol. 11, no. 4, pp. 369-73. Benaroch, M & Kauffman, R 1999, 'A Case for Using Real Options Pricing Analysis to Evaluate Information Technology Project Investments', Information Systems Research, vol. 10, no. 1, pp. 70-86. BioInnovation SA 2006, Precincts, viewed 06/11/06 2006, . Biotechnology Australia 2006, Glossary of Terms, viewed 09/09/06 2006, . Black, F & Scholes, M 1973, 'The Pricing of Options and Corporate Liabilities', Journal of Political Economy, vol. 81, no. 3, pp. 637-54.
Chapter 2 Literature Review
8
2.2 THE AUSTRALIAN BIOTECHNOLOGY SECTOR
The term biotechnology is derived through the combination of the words biology
and technology thus broadly speaking the term biotechnology can apply to any
application of technology to biological processes. Many formal definitions for
biotechnology exist. The United Nations convention on Biological Diversity offers the
broad definition:
"Biotechnology means any technological application that uses biological systems, living
organisms, or derivatives thereof, to make or modify products or processes for specific
use. (Convention on Biological Diversity 1992)
In the report titled Global Partners: Australian Biotechnology 2004 (Department of
Industry Tourism and Resources, Advance Consulting & Evaluation and Aoris Nova
2004) the Australian government adopted the OECD definition:
The application of science and technology to living organisms as well as parts,
products and models thereof, to alter living or non-living materials for the production of
goods and services. (OECD 2005)
More recently the Australian government makes a broader definition, expanding the
inference on technology to include all industrial processes:
Biotechnology describes the use of biology in industrial processes such as
agriculture, brewing and drug development. (Biotechnology Australia 2006)
These broad biotechnology definitions capture the diversity of the Australian
biotechnology sector which is made up of entities operating across different fields, all
presenting unique challenges and opportunities. The complexity and diversity of sub-
sectors in the biotechnology industry has created a number of differing segmentations
and associated definitions. Table 2-1 shows seven sub-sectors of biotechnology as
adopted by Hopper and Thorburn (2006).
Chapter 2 Literature Review
9
Table 2-1 Biotechnology Sub-Sector Definitions Biotechnology Sub-sector Definition Human Therapeutics Development of biotech-derived drugs to treat or prevent
disease, and in vitro fertilisation Agriculture Development and delivery of products and services aimed
at the agricultural sector. This may include promoting plant and animal growth, disease identification and prevention, or breeding programs
Diagnostics Development of products and tests aimed at identifying and diagnosing human disease. Biotechnology-based diagnostics include nucleic acid and monoclonal antibody-based tests, and may also include hybridisation and amplification of the target sequence. Methods in use include enzyme-linked immunoassays (ELISA), polymerase chain reaction (PCR), Random Amplification of Polymorphic DNA (RAPD), microarrays and amplified fragment-length polymorphism (AFLP). These may be supplemented by other technologies including fluorescence, nanotechnologies, filter techniques, automation and fluid flow management
Suppliers Suppliers of molecular biologicals, such as monoclonal antibodies, diagnostic reagents and gene chips
Chemical, Environmental, Other Use of biotech in mining (bioleaching), chemical development (including molecular farming) and environment (including pesticide development and bioremediation).
Food and or Beverage development of new foods (including functional foods) and food additives
Bioinformatics Application of sciences and information technologies to the organisation, management, mining and use of life-science information.
Figure 2-1 shows the proportion of firms within the Australian biotechnology sector
operating within each of the identified sub-sectors.
Figure 2-1 Australian Biotechnology Companies by Sub-sector (Hopper and Thorburn 2006)
48%
16%
14%
9%
7%
3% 3%
Human TherapeuticsAgricultureDiagnosticsSuppliersChemical, Environmental, OtherFood and/or BeveragesBioinformatics
Chapter 2 Literature Review
10
The biotechnology sector is dominated by firms whose research focuses on human
health challenges2 comprising just under two thirds of all biotechnology companies in
Australia (Hopper and Thorburn 2006). The human therapeutics sub-sector makes up
around half of all biotechnology companies in Australia and operates under unique
regulatory governance. The diversity in challenges and regulatory requirements between
firms in different biotechnology sub-sectors means that business models and value
drivers vary greatly from sub-sector to sub-sector. This thesis focuses on valuations
within the human health sub-sector. This sub-sector was chosen as the majority of
biotechnology firms fall within this category and these firms have a unique discovery
process and regulatory environment which allows particular application of
contemporary valuation methodologies.
A description of each of the stages in the development process for human therapeutics is
shown in Table 2-2. The manner in which the process is comprised of a series of
discrete components allows a biotechnology project to be modelled as a series of
decision gates, facilitating the application of contemporary financial option valuation
theory to assess project value.
2 Human health research includes both disease identification through diagnostics and disease treatment
though human therapeutics.
Chapter 2 Literature Review
11
Table 2-2 Drug Development Process Description (Allergan; US Food and Drug Administration) Development Stage Description Discovery Comprehensive study of all publicly available data
relating to the chemical entity or target therapeutic area. This review includes review of chemical and biological data and patent coverage.
Pre-Clinical Research Initial studies to show that the drug is reasonably safe for the purposes of clinical trials. Data in this stage is generated through in vitro and in vivo laboratory animal testing.
IND Investigational New Drug application filed with the regulator (the FDA in the US). Regulatory approval allows the commencement of clinical trials in humans.
Clinical Trials Phase 1 Small scale testing on around twenty to eighty (usually) healthy humans to determine the toxicity and the method of action.
Clinical Trials Phase 2 Small scale testing on around two hundred humans afflicted with the target disease to gain preliminary data regarding efficacy and further data regarding toxicity and side effects.
Clinical Trials Phase 3 Larger scale trials on humans to gather more data on efficacy and side effects to build a risk benefit profile for the drug.
NDA & Regulatory Review New Drug Application (NDA) to the regulator for assessment. All relevant data gathered during clinical and pre-clinical trials are submitted to the regulator for approval.
Product Launch & Phase 4 Trials Once approved the drug can be launched on the market. For some medicines the FDA may require additional data to monitor the long term effects of the drug.
2.2.1 Evolution of a Sector
Evolution of the modern international biotechnology market is lead by the US which is
home to the most mature and successful biotechnology market in the world. The US
industry has benefited as a result of its early adoption of biotechnology and the amount
of capital available to the industry3.
2.2.1.1 International Biotechnology
The international biotechnology market is dominated by the USA when measured by
any number of metrics. In their annual biotechnology report, Ernst and Young (2006)
claim that over three quarters of all biotechnology investment occurs in the US along
with the contribution of a similar portion of global revenues from biotechnology
3 Whilst the availability of funds to US based biotechnology companies is high by global standards, the
causal relationship with industry success is not immediately apparent. The success of the industry may be
a result of the funding availability or conversely the funding availability may be a response by the
providers of funds to industry success.
Chapter 2 Literature Review
12
products. Over one third of the worlds biotechnology companies are based in the US
and around one half of all publicly listed biotechnology companies are similarly located.
Figure 2-2 International Biotechnology Industry Comparison (Burrill 2006; Ernst & Young 2006)
Figure 2-2 provides a graphical representation showing the extent to which the US
biotechnology market dominates the global market. The US generates over 80% of
global biotechnology revenues despite only 35% of the worlds companies being based
in the US. The majority of biotechnology employees work in the US and three quarters
of global research and development expenditure occurs in the US. Cross comparison of
the pie charts reveals that the US has more employees per company than the rest of the
world and spends more on research and development per employee. By contrast, the
Asia-Pacific region has fewer employees per company and spends much less on
research and development, a symptom of funding scarcity and the lower cost bases
within which they operate.
The pie charts indicate that the Asia-Pacific region is well represented according to the
portion of the metric measuring the total number of biotechnology companies
worldwide however companies within this region are relatively small with significantly
small research and development expenditures. Canadian based biotechnology
companies display similar characteristics to those in the Asia Pacific region with a good
Chapter 2 Literature Review
13
representation of companies with relatively few employees, however research and
development expenditure per company is not as low.
Figure 2-3 International Comparison of Biotechnology Market Capitalisations (Ernst & Young 2006)
Ave. Mkt. Cap. ($b USD)
0.00
0.20
0.40
0.60
0.80
1.00
1.20
1.40
1.60
USA Europe Canada Australia Asia Pacific (ex. Aust)
Figure 2-3 provides a comparison of the average market capitalisation of biotechnology
companies located around the world. Firms listed in the US have easily the largest
market value. In the US, biotechnology companies have access to greater levels of
private funding allowing them to develop their product portfolios to a more mature state
compared with competing firms around the world. As a result, firms listing in the US
have more mature product pipelines enabling them to raise more capital at IPO.
Australian biotechnology firms are often forced to raise capital through a public listing
due to a lack of alternative funding sources (Herpin, Karuso and Foley 2005; Vitale and
Sparling 2003). As a result, many Australian biotechnology firms raising capital via an
IPO have narrower pipelines with products further from market launch compared to
their international competitors. A company with a narrow pipeline and early stage
products is a more risky investment proposition, which reduces the amount of capital
that can be raised.
2.2.1.2 Australian Biotechnology
Australia has a proven history of quality research from academic and research
institutions focused on health and medical research (Australian Government 2004).
With many biotechnology companies spawned from academic research discoveries, it is
Chapter 2 Literature Review
14
clear that our education system has helped fuel the local biotechnology industry. Whilst
Australia is a small player in the global market, it produces 3.0% of OECD life science
publications from only 0.3% of the worlds population (Economist Intelligence Unit
2005). Even though Australia is a small player in the international market Figure 2-4
shows that Australia is the dominant player in the Asian region biotechnology sector.
The majority of Asian biotechnology research and development investment expenditure,
revenues, employees and public companies come out of Australia.
Figure 2-4 Asia Pacific Biotechnology Industry Comparison (Burrill 2006; Ernst & Young 2006)
Within Australia, biotechnology head offices are concentrated in locations within the
capital cities of the eastern states, particularly Victoria and NSW as shown in Figure
2-5. Around 15% of Australian biotechnology firms were located in Queensland in 2004
and since then the state has experienced growth in biotechnology start ups at a rate
greater than the national average (Innovation Dynamics 2006).
Chapter 2 Literature Review
15
Figure 2-5 Number of Publicly Listed and Unlisted Biotechnology Firms by State (Department of Industry Tourism and Resources, Advance Consulting & Evaluation and Aoris Nova 2004, p. 14)
i Victoria
Victorian biotechnology is geographically concentrated around biotechnology precincts.
Victoria is home to the largest number of biotechnology firms, hosting around one third
of the nations firms within six high profile biotechnology precincts and around half of
all Australian biotechnology employees (Department of Industry Tourism and
Resources, Advance Consulting & Evaluation and Aoris Nova 2004). The six Victorian
biotechnology precincts are located in Melbourne and are described in Table 2-3.